Associate Director - R&D Engineering (Medical Device)
- Dublin
- Permanent
- Full-time
- Lead and mentor a small team of V&V engineers, driving all verification and validation activities.
- Develop and optimize physical test methods, fixtures, and systems to support product development and changes.
- Author technical reports, work instructions, and validation documentation.
- Execute and oversee test method validation (TMV), design verification, and transfer activities.
- Write and manage verification protocols to ensure compliance with regulatory and quality system requirements.
- Perform functional and performance testing of medical devices.
- Collaborate with cross-functional teams, suppliers, and partners to achieve V&V deliverables.
- Analyze and interpret test data, identifying out-of-spec results and supporting investigations.
- Ensure test equipment and methods are validated in line with business and regulatory standards.
- Support standards and requirements management to ensure compliance with the latest regulations.
- Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related field.
- 10+ years of experience in medical devices, pharmaceuticals, or life sciences.
- Proven experience leading technical teams.
- Strong background in developing and qualifying test systems and methods (IQ, OQ, MSA, etc.).
- Hands-on experience with design verification/validation for mechanical or electromechanical medical devices.
- Proficiency in statistical data analysis tools (e.g., Gage R&R, Hypothesis Testing, Tolerance Analysis, Minitab, SAS).
- In-depth knowledge of regulatory standards (FDA 21 CFR Part 820, EU MDR).
- Extensive understanding of risk-based validation approaches.
- Willing and eligible to travel overseas when required.
- Strong leadership and team development abilities.
- Excellent organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Highly collaborative, with advanced technical and managerial judgment.
- Self-driven, detail-oriented, and results-focused.